Screening for opisthorchiasis, a parasitic worm infection affecting many millions of people in Southeast Asia, has traditionally relied on faecal egg examination such as the formalin-ethyl acetate concentration technique (FECT) and Kato-Katz method. Although the urinary enzyme-linked immunosorbent assay (ELISA) has been used more recently, we developed a urinary antigen-based rapid diagnostic test (RDT) to simplify diagnosis and as a point-of-care testing (POCT) and field applications for surveillance and control of opisthorchiasis. A urinary Opisthorchis viverrini (OV)-RDT was developed using immunochromatographic methodology with a specific monoclonal antibody against OV. The diagnostic performance of the urinary OV-RDT was compared to that of quantitative faecal FECT and urinary antigen ELISA (n = 493). Cross-reactivities of urinary OV-RDT with other helminthiases coexisted with O. viverrini were determined (n = 96). A field trial in the application of urinary OV-RDT was compared with urinary antigen ELISA at baseline screening and assessment of drug treatment outcomes in opisthorchiasis (n = 1629). The McNemar chi-square, Kruskal–Wallis and Cohen’s kappa coefficient (κ-value) tests were used for statistical analyses. Urinary OV-RDT had sensitivity of 94.2% and specificity of 93.2%, compared to faecal FECT. Urinary OV-RDT had high diagnostic agreement (Kappa = 0.842–0.874, P < 0.001) and quantitative correlation with urinary antigen ELISA (Kruskal–Wallis tests = 316.2, P < 0.0001) and faecal FECT (Kruskal–Wallis tests = 362.3, P < 0.0001). The positive rates by OV-RDT, ELISA and FECT were 48.9%, 52.5% and 49.3%, respectively. Cross-reactions of urinary OV-RDT with other helminthiases were few (2%). Field trials of urinary OV-RDT yielded comparable prevalence of O. viverrini between urinary OV-RDT (53.2%) and urinary antigen ELISA (54.0%). OV screening showed high diagnostic agreement (kappa > 0.8, P < 0.0001) between urinary OV-RDT and urinary antigen ELISA. The cure rates of opisthorchiasis at 1 month post-praziquantel treatment determined by urinary OV-RDT (86.6%) and urinary antigen ELISA (80.5%) were similar (P > 0.05). The urinary OV-RDT test has high potential as a new tool for screening and evaluating treatment outcomes in opisthorchiasis. The ease of sample collection and simplicity of urinary OV-RDT may facilitate mass screening, control and elimination of opisthorchiasis, thereby contributing to a reduction in the disease burden in Southeast Asia.

中文翻译：

---

一种新的尿抗原快速诊断测试的准确性以及阿片吸虫病药物治疗的评估

阿片吸虫病是一种影响东南亚数百万人的寄生虫感染，传统上依赖于粪便虫卵检查，如福尔马林-醋酸乙酯浓缩技术 (FECT) 和加藤-卡茨方法。尽管最近使用了尿酶联免疫吸附测定 (ELISA)，但我们开发了一种基于尿抗原的快速诊断检测 (RDT)，以简化诊断并作为即时检测 (POCT) 和监测的现场应用和控制阿片吸虫病。使用免疫层析方法和针对 OV 的特异性单克隆抗体开发了尿液 Opisthorchis viverrini (OV)-RDT。将尿液 OV-RDT 的诊断性能与定量粪便 FECT 和尿液抗原 ELISA 的诊断性能进行比较 (n = 493)。确定了尿液 OV-RDT 与与 O. viverrini 共存的其他蠕虫病的交叉反应性 (n = 96)。一项应用尿液 OV-RDT 的现场试验与尿抗原 ELISA 在阿片吸虫病基线筛查和药物治疗结果评估方面进行了比较 (n = 1629)。McNemar 卡方、Kruskal-Wallis 和 Cohen 的 kappa 系数（κ 值）检验用于统计分析。与粪便 FECT 相比，尿液 OV-RDT 的敏感性为 94.2%，特异性为 93.2%。尿液 OV-RDT 具有较高的诊断一致性（Kappa = 0.842–0.874，P < 0.001），并且与尿液抗原 ELISA（Kruskal-Wallis 检验 = 316.2，P < 0.0001）和粪便 FECT（Kruskal-Wallis 检验 = 362.3，P）具有定量相关性。 < 0.0001)。OV-RDT、ELISA和FECT的阳性率分别为48.9%、52.5%和49.3%。尿液 OV-RDT 与其他蠕虫病的交叉反应很少 (2%)。尿 OV-RDT 现场试验得出尿 OV-RDT (53.2%) 和尿抗原 ELISA (54.0%) 之间 O. viverrini 的患病率相当。OV 筛查显示尿 OV-RDT 和尿抗原 ELISA 之间的诊断一致性很高（kappa > 0.8，P < 0.0001）。吡喹酮治疗后1个月尿OV-RDT（86.6%）和尿抗原ELISA（80.5%）测定的阿片吸虫病治愈率相似（P > 0.05）。尿液 OV-RDT 检测具有作为筛查和评估阿片吸虫病治疗结果的新工具的巨大潜力。尿液 OV-RDT 样本采集的简便性和简单性可能有助于大规模筛查、控制和消除阿片吸虫病，从而有助于减轻东南亚的疾病负担。